Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children

NCT04484935 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: D5290C000082021-003221-30
• Study Type: interventional
• Target: 100
• Locations: 8 countries
• Sites: 28

Brief Summary

Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, pharmacokinetic(s) (PK), occurrence of antidrug antibody (ADA), and efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time of dose administration. Approximately 100 subjects will be enrolled. Subjects will be followed for approximately 1 year after dose administration.

Conditions

RSV Infection

Keywords

LRTI by RSV infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs (TESAEs), AEs of Special Interest (AESIs), and New Onset Chronic Disease (NOCDs)

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab and within 360 days post dose. A TESAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant. AESIs were defined as AEs of immediate (type I) hypersensitivity (including anaphylaxis), thrombocytopenia, and immune complex disease following the administration of nirsevimab based on investigator assessment and Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) codes. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature post administration of treatment.

  TEAEs were collected from the first dose administration (Day 1) up to 360 days post dose

Secondary Outcomes (3)

• Serum Concentrations of Nirsevimab

  Baseline (Day 1) and on Days 8 (for Japanese participants), 31, 151 and 361

• Number of Participants With Anti-Drug Antibody (ADA) Response to Nirsevimab

  Baseline (Day 1) and on Days 31, 151 and 361

• Number of Participants With Medically Attended (MA) RSV LRTI (Inpatient and Outpatient) and Hospitalizations

  Through 150 days post dose

Study Arms (1)

Nirsevimab

EXPERIMENTAL

1st RSV season: 50mg nirsevimab 1. st RSV season: 100mg nirsevimab 2. nd RSV season: 200mg nirsevimab

Drug: Nirsevimab

Interventions

Nirsevimab DRUG

Single fixed IM dose of nirsevimab 50 mg if body weight \< 5 kg or 100 mg if body weight ≥ 5 kg, and subjects entering their second RSV season will receive a single fixed IM dose of nirsevimab 200 mg

Also known as: Nirsevimab (MEDI8897)

Nirsevimab

Eligibility Criteria

• Age: 0 Years - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonate, infant, or young child ≤ 24 months of age at the time of dose administration who, per investigator judgement, are:
• In their first year of life AND entering their first RSV season at the time of dose administration OR
• In their second year of life AND entering their second RSV season at the time of dose administration
• The subject must meet at least 1 of the following conditions at the time of informed consent.
• Diagnosed with combined immunodeficiency (severe combined immunodeficiency, X-linked hyper-immunoglobulin M \[IgM\] syndrome, etc); antibody deficiency (X linked agammaglobulinemia, common variable immunodeficiency, non-X-linked hyper-IgM syndromes, etc); or other immunodeficiency (Wiskott-Aldrich syndrome, DiGeorge syndrome, etc), or
• Diagnosed with human immunodeficiency virus infection, or
• History of organ or bone marrow transplantation, or
• Subject is receiving immunosuppressive chemotherapy, or
• Subject is receiving systemic high-dose corticosteroid therapy (prednisone equivalents ≥ 0.5 mg/kg every other day, other than inhaler or topical use), or
• Subject is receiving other immunosuppressive therapy (eg, azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc)
• Written informed consent and any locally required authorization obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations.
• Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up visits as judged by the investigator.
• Subject is available to complete the follow-up period, which will be approximately 1 year after receipt of nirsevimab

You may not qualify if:

• Subject who meets any of the palivizumab indications approved in Japan other than immunocompromised condition.
• Subject born at ≤ 28 weeks gestation and is ≤ 12 months of age
• Subject born at 29 to 35 weeks gestation and is ≤ 6 months of age
• Age ≤ 24 months with a history of bronchopulmonary dysplasia requiring medical management within the past 6 months
• Age ≤ 24 months with current hemodynamically significant congenital heart disease (CHD)
• Age ≤ 24 months with Down syndrome
• Requirement for oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, or other mechanical respiratory or cardiac support at screening
• A current, active infection, including RSV infection, at the time of screening or at the time of investigational product administration.
• Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or acute illness within 7 days prior to investigational product administration.
• Any serious concurrent medical condition (renal failure, hepatic dysfunction, suspected active or chronic hepatitis infection, seizure disorder, unstable neurologic disorder, etc), except those resulting in an immune deficiency condition.
• Clinically significant congenital anomaly of the respiratory tract.
• Receipt of palivizumab.
• Any known allergy or history of allergic reaction to any component of nirsevimab.
• Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins.
• Concurrent enrollment in another interventional study, or prior receipt of any investigational agent.

Sponsors & Collaborators

• AstraZeneca: lead
• Iqvia Pty Ltd: collaborator

Study Sites (28)

Research Site

Los Angeles, California, 90027, United States

Location

Research Site

Tampa, Florida, 33606, United States

Location

Research Site

Syracuse, New York, 13210, United States

Location

Research Site

North Charleston, South Carolina, 29406, United States

Location

Research Site

Memphis, Tennessee, 38105, United States

Location

Research Site

Fort Worth, Texas, 76104, United States

Location

Research Site

Tacoma, Washington, 98405, United States

Location

Research Site

Brussels, 1200, Belgium

Location

Research Site

Liège, 4000, Belgium

Location

Research Site

Bunkyō City, 113-8519, Japan

Location

Research Site

Fuchu-shi, 183-8561, Japan

Location

Research Site

Kawasaki-shi, 216-8511, Japan

Location

Research Site

Kurume-shi, 830-0011, Japan

Location

Research Site

Kyoto, 606-8507, Japan

Location

Research Site

Nagasaki, 852-8501, Japan

Location

Research Site

Setagaya-ku, 157-8535, Japan

Location

Research Site

Tsukuba, 305-8576, Japan

Location

Research Site

Yokohama, 232 8555, Japan

Location

Research Site

Bydgoszcz, 85-048, Poland

Location

Research Site

Parktown, 2193, South Africa

Location

Research Site

Soweto, 2013, South Africa

Location

Research Site

Barcelona, 8035, Spain

Location

Research Site

Granada, 18014, Spain

Location

Research Site

Madrid, 28041, Spain

Location

Research Site

Madrid, 28046, Spain

Location

Research Site

Dnipro, 49006, Ukraine

Location

Research Site

Kharkiv, 61075, Ukraine

Location

Research Site

Nottingham, NG7 2UH, United Kingdom

Location

Related Links

• CSRsynopsis
• CSP
• SAP

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

nirsevimab

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open: no masking is used. All involved know the identity of the intervention assignment.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 24, 2020
• Study Start: August 19, 2020
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: November 15, 2023
• Results First Posted: November 15, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

JP (9); ES (4); US (7); PL (1); GB (1); ZA (2); UA (2); BE (2)